pp65 RNA-LPs Vaccine(University of Florida) in Recurrent Glioblastoma: NCT06389591 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 15 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Active, not recruiting
Recruitment status
not reported
Planned enrollment
2026-12-01
Primary-completion proxy
Executive view
NCT06389591 evaluates pp65 RNA-LPs Vaccine(University of Florida) in Recurrent Glioblastoma. The disclosed sponsor is University of Florida, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines, assessed over from the date of surgery until administration of third vaccine, up to 20 weeks.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT06389591 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Recurrent Glioblastoma landscape. Drug & Asset MCP drug_fetch was queried for pp65 RNA-LPs Vaccine(University of Florida), while Company & Deal Intelligence MCP organization_fetch was queried for University of Florida.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT06389591 | pp65 RNA-LPs Vaccine(University of Florida) | Phase 1 / Active, not recruiting | University of Florida | United States | Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines from the date of surgery until administration of third vaccine, up to… | 2026-12-01 |
| NCT06703255 | Temozolomide | Phase 1/2 / Recruiting | Hangzhou Hansi Biological Pharmaceutical Co., Ltd. | China | Part I: Number of participants experiencing Adverse Events (AEs) All AEs up to 28(±7)days after the last dose of study treatment | 2026-12-31 |
| NCT06691308 | WL-276 (Imunopharm) | Early Phase 1 / Not yet recruiting | Beijing Imunopharm Technology Co., Ltd. | Geography not reported | Evaluate the safety（Adverse event incidence rate、Incidence rate of abnormal laboratory test results） and tolerability（D… Within 28 days after infusion | 2027-05-31 |
| NCT06687681 | Allogenic NK cell(Kian Immune Cell Company) | Phase 2 / Recruiting | Kian immune Cell Company | Iran | To measure tumor response after infusion of intrathecal NK cells From enrollment to the end of treatment at 12 months | 2025-11-25 |
| NCT06672575 | Ivonescimab | Phase 1/2 / Recruiting | The University of Texas MD Anderson Cancer Center | United States | Safety and Adverse Events (AEs) Through study completion; an average of 1 year | 2028-01-31 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT06389591 is a Phase 1, active, not recruiting study with not reported planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines” over “from the date of surgery until administration of third vaccine, up to 20 weeks.” The retrieved endpoint description is: Manufacturing feasibility will be determined based on the percentage of vaccines that are successfully manufactured in the DLT window during the first three vaccines. If two-thirds of vaccines are successfully manufactured with Qa/Qc clearance, the investigators will conclude that RNA-LPs can be successfully manufactured..
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of not reported should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
0 recent result records were selected as contextual evidence for Recurrent Glioblastoma. These records do not establish direct evidence for NCT06389591 unless the registration number matches.
Indexed evidence status
No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
pp65 RNA-LPs Vaccine(University of Florida) is indexed as Therapeutic vaccine with target not reported biology and a global stage of Phase 1. The asset profile lists University of Florida as an originator or developer.
University of Florida is indexed in an unreported country with the website http://www.ufl.edu. University of Florida is a public land-grant research university in Gainesville, Florida. The record lists 119 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether pp65 RNA-LPs Vaccine(University of Florida) is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT06389591
Protocol source: https://clinicaltrials.gov/study/NCT06389591
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 15 October 2026.
pp65 RNA-LPs Vaccine(University of Florida) in Recurrent Glioblastoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines and 2026-12-01 the leading decision points.
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